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Related Experiment Video

Updated: Jul 16, 2026

An Anesthesia, Surgery, and Harvest Method for the Evaluation of Transpedicular Screws Using an In Vivo Porcine Lumbar Spine Model

An Anesthesia, Surgery, and Harvest Method for the Evaluation of Transpedicular Screws Using an In Vivo Porcine Lumbar Spine Model

Published on: May 31, 2017

A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery.

K L Renkens¹, T D Payner, T J Leipzig

¹Indianapolis Neurosurgical Group, Indiana 46202, USA. krenkens@iquest.net

|July 28, 2001

Summary

Proceed, a gelatin-based hemostatic sealant, effectively stopped intraoperative bleeding in 98% of spinal surgery patients. This study confirms Proceed is as safe as Gelfoam-thrombin for hemostasis.

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Pre-Chiasmatic, Single Injection of Autologous Blood to Induce Experimental Subarachnoid Hemorrhage in a Rat Model

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Published on: June 18, 2021

Area of Science:

Neurosurgery
Surgical Hemostasis
Medical Device Evaluation

Background:

Proceed is a gelatin-based hemostatic sealant tested in animal models.
This study evaluated Proceed's safety and effectiveness in humans under an FDA Investigational Device Exemption.

Purpose of the Study:

To determine the effectiveness of Proceed in controlling intraoperative bleeding during spinal surgery.
To assess the safety profile of Proceed compared to a control agent.

Main Methods:

A prospective, randomized trial involving 127 patients undergoing spinal surgery.
Patients were randomized to receive either Proceed (treatment) or Gelfoam-thrombin (control) after standard bleeding control methods failed.
Hemostasis was evaluated at 1, 2, 3, 6, and 10 minutes post-application, with follow-up at 12-36 hours and 6-8 weeks.

Main Results:

Proceed achieved hemostasis in 98% of patients within 10 minutes, versus 90% for the control group (P=0.001).
At 3 minutes, 97% of the Proceed group achieved hemostasis compared to 71% in the control group (P=0.0001).
No significant difference in adverse events was observed between the two groups.

Conclusions:

Proceed demonstrated significantly faster hemostasis compared to Gelfoam-thrombin at 1, 2, and 3 minutes.
Proceed was found to be as safe as Gelfoam-thrombin for use in spinal surgery hemostasis.